Orange Book product · Brand (NDA)

OMONTYS

PEGINESATIDE ACETATE

Brand (NDA)NDA 202799DISCN TAKEDA PHARMS USA

Mar 27, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 27, 2012
14 yr 5 mo ago
Patent 7550433 expires
Listed method-of-use patent (U-1238) expiration.
Jun 02, 2026
17 d ago
Patent 7919461 expires
Listed method-of-use patent (U-1238) expiration.
Jun 02, 2026
17 d ago
Today

Active ingredient

PEGINESATIDE ACETATE

Strength

EQ 10MG BASE/ML (EQ 10MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS, SUBCUTANEOUS

TE code

Not listed

Application

NDA 202799

Product number

007

Marketing status

DISCN

Reference listed drug (RLD)

Reference standard (RS)

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7550433	Jun 02, 2026	17 d ago	U-1238
7919461	Jun 02, 2026	17 d ago	U-1238